# K251577: Laia XR

- Pathway: 510(k) (Traditional)
- Applicant: Augmented Reality Software S.L.
- Decided: Feb 6, 2026 after 260 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K913770 (1991). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213215: VSI HoloMedicine, Apoqlar GmbH (2022) Summary page 5.

## Indications for use
LAIA XR is a software device for displaying digital medical images, especially for CT and MR images (DICOM format). It is intended to visualize 3D medical imaging of the patient for pre-operative planning outside the surgical room. When accessing LAIA XR from a wired head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. LAIA XR is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists.

Source page: https://510kreport.com/device/K251577
Methodology: https://510kreport.com/methodology